Use of topical corticosteroid pretreatment to reduce the incidence and severity of skin reactions associated with testosterone transdermal therapy

Wilson, Douglas E.; Kaidbey, Kays H.; Boike, Steven C.; Jorkasky, Diane K.

doi:10.1016/s0149-2918(98)80093-3

Cited by 54 publications

(24 citation statements)

References 8 publications

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“…The most frequently reported adverse events with TTD were related to local irritation from the patches, a common finding with transdermal delivery systems (30). Recent clinical studies have shown that applying a small amount of 0.1% triamcinolone acetonide cream to the skin under the Androderm patch reservoir reduces the incidence and severity of skin irritation and does not significantly alter transdermal absorption (7,31,32).…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men*

Dobs

Meikle

Arver

et al. 1999

The Journal of Clinical Endocrinology &Amp; Metabolism

126

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The pharmacokinetics, efficacy, and safety of the Androderm testosterone (T) transdermal system (TTD) and intramuscular T enanthate injections (IM) for the treatment of male hypogonadism were compared in a 24-week multicenter, randomized, parallel-group study. Sixty-six adult hypogonadal men (22-65 years of age) were withdrawn from prior IM treatment for 4 -6 weeks and then randomly assigned to treatment with TTD (two 2.5-mg systems applied nightly) or IM (200 mg injected every 2 weeks); there were 33 patients per group. Twenty-six patients in the TTD group and 32 in the IM group completed the study.TTD treatment produced circadian variations in the levels of total T, bioavailable T, dihydrotestosterone, and estradiol within the normal physiological ranges. IM treatment produced supraphysiological levels of T, bioavailable T, and estradiol (but not dihydrotestosterone) for several days after each injection. Mean morning sex hormone levels were within the normal range in greater proportions of TTD patients (range, 77-100%) than IM patients (range, 19 -84%). Both treatments normalized LH levels in approximately 50% of patients with primary hypogonadism; however, LH levels were suppressed to the subnormal range in 31% of IM patients vs. 0% of TTD patients. Both treatments maintained sexual function (assessed by questionnaire and Rigiscan) and mood (Beck Depression Inventory) at the prior treatment levels.Prostate-specific antigen levels, prostate volumes, and lipid and serum chemistry parameters were comparable in both treatment groups. Transient skin irritation from the patches was reported by 60% of the TTD patients, but caused only three patients (9%) to discontinue treatment. IM treatment produced local reactions in 33% of patients and was associated with significantly more abnormal hematocrit elevations (43.8% of patients) compared with TTD treatment (15.4% of patients). Gynecomastia resolved more frequently during TTD treatment (4 of 10 patients) than with IM treatment (1 of 9 patients).Although both treatments seem to be efficacious for replacing T in hypogonadal men, the more physiological sex hormone levels and profiles associated with TTD may offer possible advantages over IM in minimizing excessive stimulation of erythropoiesis, preventing/ ameliorating gynecomastia, and not over-suppressing gonadotropins. (J Clin Endocrinol Metab 84: 3469 -3478, 1999)

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Section: Discussionmentioning

confidence: 99%

Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men*

Dobs

Meikle

Arver

et al. 1999

The Journal of Clinical Endocrinology &Amp; Metabolism

126

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“…Their main drawback is that in order to facilitate absorption, enhancers that cause skin irritation of varying severity are required [111]. Although this cutaneous irritation can be prevented or improved with topical corticoids [112], 10–20% of patients abandon the treatment due to this side effect. More recently, a gel for the transdermal administration of testosterone has appeared on the market [113].…”

Section: Hypogonadismmentioning

confidence: 99%

Ascertainment and Treatment of Delayed Puberty

Pozo

Argente²

2003

Horm Res Paediatr

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The majority of patients with pubertal delay, can be classified as having primary pubertal delay (constitutional delay of growth and puberty, CDGP), although any child with a chronic disease could present with delayed puberty. In contrast, children with hypogonadism, either hyper- or hypogonadotropic, exhibit a total absence of pubertal development. Hence, early evaluation of these patients should be performed. Delay of puberty leads to psychological problems, secondary to short stature and/or delay in the acquisition of secondary sex characteristics and the reduction of bone mass. Although the final height in patients with CDGP is usually normal, some of these patients do not reach the third percentile or remain in the lowest part of the growth chart according to familial height. The most common reason for treating CDGP patients, usually with sex steroids, is for psychological difficulties and for loss of bone mineralization. Treatment must be individualized. Therapeutic options and new drugs will be discussed. Appropriate treatment and adequate nutritional intake are indicated in patients with delayed puberty due to chronic illness. In patients with hypo- or hypergonadotropic hypogonadism, puberty must be induced or completed. Different treatments (GnRH analogues, gonadotropins and sex steroids), and the main objectives are discussed.

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“…No relevant skin irritation, itching and burning sensations were reported after increasing the dose of Testopatch ® applications, thus avoiding the use of topical corticosteroids pretreatment as previously reported [27,28]. Patches were well tolerated during the 48 h period of application and not associated with relevant abnormal clinical investigations.…”

Section: Discussionmentioning

confidence: 53%

Pharmacokinetic study of a new testosterone-in-adhesive matrix patch applied every 2 days to hypogonadal men

Raynaud

Aumonier²,

Gualano³

et al. 2008

The Journal of Steroid Biochemistry and Molecular Biology

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Use of topical corticosteroid pretreatment to reduce the incidence and severity of skin reactions associated with testosterone transdermal therapy

Cited by 54 publications

References 8 publications

Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men*

Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men*

Ascertainment and Treatment of Delayed Puberty

Pharmacokinetic study of a new testosterone-in-adhesive matrix patch applied every 2 days to hypogonadal men

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